Multimodal Ocular Imaging in Neurodegeneration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- University of Michigan
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Presence of Retinal Thinning
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Alzheimer's disease (AD) and frontotemporal dementia (FTD) are two of the most common types of age-related neurodegenerative disorders. Identifying at-risk patients and gauging disease progression in a non-invasive manner would be invaluable. Early and correct diagnosis is crucial for coordinating supportive care, patient expectations, caregiver arrangements and family planning. In addition, as treatments become available, beginning therapy early in the disease before symptoms become severe will be important. Multimodal ocular imaging (MOI) includes an ophthalmic (eye) exam and eye photographs to evaluate different layers of the retina, which is the light sensing layer of the eye. Newer technologies make it possible to visualize the disease process occurring in AD and FTD by using MOI to look at the retina, since the retina is fundamentally an outward extension of the brain itself. This study will attempt to correlate signs of disease in the retina, as determined by MOI, with plaque buildup in the brain as seen by imaging. This will demonstrate the sensitivity and specificity of MOI for diagnosing AD and FTD in a noninvasive manner.
Investigators
Cagri Besirli
Associate Professor of Ophthalmology
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •Subjects with dementia must have known diagnosis of Alzheimer's dementia (AD) or frontotemporal dementia (FTD)
- •Subjects with dementia must have Moderate/severe dementia as preferentially defined by a documented MoCA score of less than 17, or by MMSE score of less than 17, within the last 12 months
- •Individuals with no evidence of AD or FTD as age-matched controls.
Exclusion Criteria
- •Preexisting retinal or optic nerve disorder including macular degeneration, diabetic retinopathy, retinal dystrophy, and glaucoma
- •Anterior segment abnormalities of the eye limiting ocular imaging (e.g. corneal disorders, dense cataract).
- •Use of medications with known effects on the retina or optic nerve (e.g. hydroxychloroquine, ethambutol).
- •Pregnant or lactating women.
- •Prisoners.
- •Subjects with advanced dementia who cannot be independently and reliably positioned at the ocular imaging device for reliable imaging.
- •Subjects with contraindications to magnetic resonance (MR) imaging, including pacemakers or claustrophobia.
- •Evidence of large vessel stroke or mass lesion identified on MR imaging.
- •Subjects limited by participation in research procedures involving ionizing radiation.
- •Subjects who are already participating in another clinical study or clinical trial
Outcomes
Primary Outcomes
Presence of Retinal Thinning
Time Frame: 45 minutes
Imaging of the eye will be used to measure differences in retinal thickness between subjects with Alzheimer's Dementia, Frontotemporal Dementia, and healthy age-matched controls.
Secondary Outcomes
- Presence of Brain Metabolism(180 Minutes)
- Presence of Amyloid Plaque(45 Minutes)
- Presence of Brain Pathology(60 Minutes)
- Presence of Macular Vascular Anomalies(45 Minutes)